title: Development of FlexSure HP--an immunochromatographic method to detect antibodies against Helicobacter pylori.
abstract: We describe a solid-phase immunochromatographic serologic test, FlexSure HP, to detect IgG antibodies against Helicobacter pylori. H. pylori colonize the stomach and proximal duodenum, cause ulcer disease and mucosa-associated lymphoid tissue lymphoma, and have a role in the development of other disorders, including gastric adenocarcinoma. FlexSure HP consists of a test strip, conjugate pad, and absorbent pad, in a novel reverse-flow chromatography format. In these studies, FlexSure HP was demonstrated to be specific for IgG antibodies against H. pylori. The reactive cutoff of the test was consistent with [13C]urea breath test and commercially available ELISAs. FlexSure HP had 94% sensitivity, 88% specificity, and 91% accuracy relative to [13C]urea breath test; and 95% sensitivity, 94% specificity, and 95% overall agreement relative to high-molecular-mass cell-associated protein enzyme immunoassay (HM-CAP EIA). FlexSure HP is a simple-to-perform, visually read test requiring no specialized training, equipment, or instrumentation, and yields rapid, accurate, qualitative results.
authors.affiliation: SmithKline Diagnostics, Inc., Palo Alto, CA 94303, USA.
authors.forename: W H
authors.initials: WH
authors.lastname: Schrier
authors.forename: R J
authors.initials: RJ
authors.lastname: Schoengold
authors.forename: J T
authors.initials: JT
authors.lastname: Baker
authors.forename: J L
authors.initials: JL
authors.lastname: Norell
authors.forename: C L
authors.initials: CL
authors.lastname: Jaseph
authors.forename: Y
authors.initials: Y
authors.lastname: Okin
authors.forename: J Y
authors.initials: JY
authors.lastname: Doe
authors.forename: H
authors.initials: H
authors.lastname: Chandler
mesh_terms: D000328:Adult; D000906:Antibodies / Q000097:blood*; D000942:Antigens, Bacterial / Q000097:blood / Q000276:immunology; D001944:Breath Tests; D003429:Cross Reactions / Q000276:immunology; D005260:Female; D016481:Helicobacter Infections / Q000097:blood* / Q000276:immunology; D016480:Helicobacter pylori / Q000276:immunology*; D006801:Humans; D007164:Immunosorbents / Q000378:metabolism; D008297:Male; D008875:Middle Aged; D012372:ROC Curve; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D013270:Stomach / Q000382:microbiology; D014508:Urea / Q000032:analysis
chemical_list: D000906:Antibodies; D000942:Antigens, Bacterial; D007164:Immunosorbents; D011933:Reagent Kits, Diagnostic; D014508:Urea